56 results · 20ms · Sources: EU EUDAMED, US FDA

HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Kit, Test, Olfactory

FDA classification
FDA Class 2 ·Kit, Test, Olfactory

OOCYTE ASPIRATION NEEDLE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BIOJET

FDA 510(k)
FDA Class 2 ·Radiology

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

FDA 510(k)
FDA Class 2 ·Anesthesiology

ARK Fentanyl Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

NICOLET ARK SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

BRK TRANSSEPTAL NEEDLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARK Tramadol Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Hydrocodone Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK EDDP Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Lacosamide Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

LapBox Power Tissue Containment System

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

VIMPLANT

FDA 510(k)
FDA Class 2 ·Radiology

ACCUREX

FDA 510(k)
FDA Class 2 ·Radiology

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CARPAL ENGAGING WRIST FUSION PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

AQUA ARK, IMMERSION HYDROBATH

FDA 510(k)
FDA Class 2 ·Physical Medicine

Reprocessed BRK Transseptal Needle

FDA 510(k)
FDA Class 2 ·Cardiovascular